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PaREnting ProgrAm to Enhance PREterm Infants' Health and Development (PREPARE Trial) (PREPARE)

Primary Purpose

Behavioral Assessment of Children, Early Intervention

Status
Recruiting
Phase
Not Applicable
Locations
Lebanon
Study Type
Interventional
Intervention
Comprehensive structured parent intervention
Sponsored by
American University of Beirut Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Behavioral Assessment of Children focused on measuring Preterm infant, Parental stress, Early child development, Parenting in the neonatal intensive care

Eligibility Criteria

1 Day - 21 Days (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Couplets of parents and their preterm infants admitted to the NICU, who are <35 weeks gestation at birth and who are deemed medically stable by their treating neonatologist.

Exclusion Criteria:

  • Infants with significant neurologic disorder precluding meaningful interaction with the parents as determined by the neurologist
  • Infants with major congenital anomalies precluding meaningful interaction with the parents as determined by the neurologist
  • Infants with systemic medical and/ or surgical conditions precluding interaction with the parents, other than preterm-related intraventricular hemorrhage (IVH) and periventricular leukomalacia (PVL).
  • Parental refusal to participate
  • Absence of clearance from the neonatologist
  • Infants planned to be transferred to another facility for their NICU care.

Sites / Locations

  • American University of BeirutRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

The parents of babies in this group will receive an educational and intervention program

The parents of babies in this group will receive the standard parent education and follow-up.

Outcomes

Primary Outcome Measures

Child developmental outcome
The developmental outcome of preterm children will be assessed using the Ages and Stages Questionnaire at 9 months of corrected age. The ASQ-3 covers 5 area of child development : Gross Motor, Fine Motor, Problem Solving, Personal-Social, Communication. Scores for each area should range between minimum 0 and maximum 60. Higher scores indicate that the child is developing properly.

Secondary Outcome Measures

Physiological state- Respiratory rate
Physiological parameters including respiratory rate will be retrieved from the bedside monitors.
Physiological state - Oxygen saturation
Physiological parameters including oxygen saturation will be retrieved from the bedside monitors.
Neurobehavioral state
Behavioral state will be assessed by a cerified trained developmental specialist using a 7-point score that include: (i) Quiet/deep sleep, (ii) Active sleep, (iii) Awake State, (iv) drowsy, (v) quiet alert, (vi) active alert, (vii) crying
Parental Knowledge assessment
Parental knowledge assessment test will be administered before and after the education sessions using 10 true/false questions regarding topics addressed in the sessions.
Parental stress
The Arabic parenting stress index short form questionnaire will be used. The PSI-SF is a self-administered questionnaire and consists of 36 items divided into three subscales of 12 items each: parental distress, parent-child dysfunctional interaction and difficult child. For each subscales scores ranges should be between 12 and 60. For the total stress score , the minimum score is 36 and the maximum is 180. Higher scores mean more depressive symptoms.
Behavioral parenting activities
A questionnaire derived from the UNICEF MICS 6 questionnaire will be used. MICS or "MULTIPLE INDICATOR CLUSTER SURVEY" is a tool used to assess the activities of parents with their infants.
Parents perceptions
The Perceived Maternal Parenting Self-Efficacy questionnaire is a standardized valid and reliable instrument to assess parent's perceptions of their ability to care for their infants. PMP-SE is composed of 20 items divided into four subscales: care taking procedures, evoking behaviours, reading behaviours or signalling, and situational beliefs. Those items are formulated as statements using a five-point Likert scale. Scoring ranges from 20 to 80 where a higher score indicates a higher self-efficacy.

Full Information

First Posted
January 15, 2021
Last Updated
February 8, 2023
Sponsor
American University of Beirut Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04783220
Brief Title
PaREnting ProgrAm to Enhance PREterm Infants' Health and Development (PREPARE Trial)
Acronym
PREPARE
Official Title
Comprehensive PaREnting ProgrAm to Enhance PREterm Infants' Health and Development: A Randomized Controlled Trial (PREPARE Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
January 30, 2024 (Anticipated)
Study Completion Date
January 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
American University of Beirut Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Preterm infants are at high risk of developmental delay or disabilities and they do benefit from early intervention programs. Many programs aiming at improving preterm infants' developmental outcome have been proposed with mixed results. In low to middle-income countries, clinically relevant and effective low cost interventions empowering parents have yet to be established.
Detailed Description
Education and intervention programs targeting parents of premature infants are lacking in low to middle income countries (LMIC) and in Arabic countries in particular. The main concept of this proposal is to develop a program in Arabic for parents of premature infants with the aim to increase their knowledge about short and long term problems of prematurity, increase their involvement in the care during their stay in the neonatal intensive care unit (NICU) and promote responsive and sensitive parenting in the NICU and after discharge. This is to empower parents and have them become active contributors to enhancing their infant's development through play activities and tracking of developmental milestones.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Behavioral Assessment of Children, Early Intervention
Keywords
Preterm infant, Parental stress, Early child development, Parenting in the neonatal intensive care

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
The parents of babies in this group will receive an educational and intervention program
Arm Title
Control
Arm Type
No Intervention
Arm Description
The parents of babies in this group will receive the standard parent education and follow-up.
Intervention Type
Behavioral
Intervention Name(s)
Comprehensive structured parent intervention
Intervention Description
Educational sessions and coaching on infants' behavior cues Skills on motor stimulation Written instructions for play and stimulation activities at discharge Multidisciplinary follow-up Developmental tracking and advice via a mobile app
Primary Outcome Measure Information:
Title
Child developmental outcome
Description
The developmental outcome of preterm children will be assessed using the Ages and Stages Questionnaire at 9 months of corrected age. The ASQ-3 covers 5 area of child development : Gross Motor, Fine Motor, Problem Solving, Personal-Social, Communication. Scores for each area should range between minimum 0 and maximum 60. Higher scores indicate that the child is developing properly.
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Physiological state- Respiratory rate
Description
Physiological parameters including respiratory rate will be retrieved from the bedside monitors.
Time Frame
1 year
Title
Physiological state - Oxygen saturation
Description
Physiological parameters including oxygen saturation will be retrieved from the bedside monitors.
Time Frame
1 year
Title
Neurobehavioral state
Description
Behavioral state will be assessed by a cerified trained developmental specialist using a 7-point score that include: (i) Quiet/deep sleep, (ii) Active sleep, (iii) Awake State, (iv) drowsy, (v) quiet alert, (vi) active alert, (vii) crying
Time Frame
1 year
Title
Parental Knowledge assessment
Description
Parental knowledge assessment test will be administered before and after the education sessions using 10 true/false questions regarding topics addressed in the sessions.
Time Frame
Before hospital discharge
Title
Parental stress
Description
The Arabic parenting stress index short form questionnaire will be used. The PSI-SF is a self-administered questionnaire and consists of 36 items divided into three subscales of 12 items each: parental distress, parent-child dysfunctional interaction and difficult child. For each subscales scores ranges should be between 12 and 60. For the total stress score , the minimum score is 36 and the maximum is 180. Higher scores mean more depressive symptoms.
Time Frame
1 year
Title
Behavioral parenting activities
Description
A questionnaire derived from the UNICEF MICS 6 questionnaire will be used. MICS or "MULTIPLE INDICATOR CLUSTER SURVEY" is a tool used to assess the activities of parents with their infants.
Time Frame
1 year
Title
Parents perceptions
Description
The Perceived Maternal Parenting Self-Efficacy questionnaire is a standardized valid and reliable instrument to assess parent's perceptions of their ability to care for their infants. PMP-SE is composed of 20 items divided into four subscales: care taking procedures, evoking behaviours, reading behaviours or signalling, and situational beliefs. Those items are formulated as statements using a five-point Likert scale. Scoring ranges from 20 to 80 where a higher score indicates a higher self-efficacy.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
21 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Couplets of parents and their preterm infants admitted to the NICU, who are <35 weeks gestation at birth and who are deemed medically stable by their treating neonatologist. Exclusion Criteria: Infants with significant neurologic disorder precluding meaningful interaction with the parents as determined by the neurologist Infants with major congenital anomalies precluding meaningful interaction with the parents as determined by the neurologist Infants with systemic medical and/ or surgical conditions precluding interaction with the parents, other than preterm-related intraventricular hemorrhage (IVH) and periventricular leukomalacia (PVL). Parental refusal to participate Absence of clearance from the neonatologist Infants planned to be transferred to another facility for their NICU care.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lama Charafeddine, MD
Phone
009611350000
Ext
5874
Email
lc12@aub.edu.lb
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lama Charafeddine, MD
Organizational Affiliation
American University of Beirut Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
American University of Beirut
City
Beirut
State/Province
Hamra
ZIP/Postal Code
1107 2020
Country
Lebanon
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lama Charafeddine, MD
Phone
009611350000
Ext
5874
Email
lc12@aub.edu.lb

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://mics.unicef.org/tools
Description
MICS6 TOOLS
URL
http://healthit.ahrq.gov/ahrq-funded-projects/nicu-2-home-using-health-it-support-parents-nicu-graduates-transitioning-home
Description
Agency for Healthcare Reserach and Quality (2018). NICU-2-HOME: Using Health IT to Support Parents of NICU Graduates Transitioning to Home (Illinois) | AHRQ National Resource Center; Health Information Technology: Best Practices Transforming Quality, S

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PaREnting ProgrAm to Enhance PREterm Infants' Health and Development (PREPARE Trial)

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